Kornimate/medical-research-clean huggingface dataset:
cryoablation vs antiarrhythmic drugs for persistent atrial fibrillation trial

Conditions: Atrial Fibrillation

Summary: this is a prospective, randomized, multicenter study comparing the relative efficacy and safety of cryoablation of pvs using the arctic front advance® balloon catheter with antiarrhythmic therapy in patients with persistent af.

the ablation of pulmonary veins is a very effective treatment for the treatment of paroxysmal atrial fibrillation. the benefit of the isolation of pulmonary veins in persistent atrial fibrillation seems to be minor and the level of scientific evidence available requires additional clinical trials to define the value of ablation in this type of patients. the symptomatology of atrial fibrillation recurrences is variable among patients and among differens moments in the same patient. pharmacological treatment and ablation have been used to reduce the symptomatology of atrial fibrillation recurrences and to increase the proportion of asymptomatic recurrences. different forms of electrical monitoring of the heart rate are used to evaluate the effectiveness of an intervention. frequents monitoring periods provide the information of the heart rate and the effect of any intervention. the "confirm rx heart monitor® (abbott)" is a subcutaneous implantable device that provides continuous monitoring of the heart rate for more than 3 years without any effect on cardiac function. this implantable holter automatically detects and saves atrial and ventricular arrhythmic episodes. the device can be analyzed in person or remotely, and can help to make decisions regarding anticoagulant and antiarrhythmic treatment of patients, while representing a powerful research tool for evaluate the effectiveness of different therapeutic options. this is a prospective, randomized, multicenter study that compares the relative efficacy and safety of cryoablation of pulmonary veins using the arctic front advance® balloon catheter with antiarrhythmic treatment in patients with persistent atrial fibrilation.

Eligibility criteria:
inclusion criteria: * patients with recurrent persistent atrial fibrilation exclusion criteria: * patients with atrial fibrilation for more than one year at baseline * atrial fibrilation prior ablation * age\> 75 years or \<18 years * hyperthyroidism * hypertrophic cardiomyopathy * severe valvular disease (stenosis or regurgitation) * carriers of cardiac valves * anteroposterior diameter of left atrium\> 50 mm (left parasternal long axis) * contraindications for anticoagulation * left atrial thrombus * anemia * active infection * pregnancy * atrial fibrilation secondary to transient, avoidable or correctable causes (hyperthyroidism, pneumonia, pulmonary embolism, drugs, hydroelectrolytic alterations ...) * life expectancy of less than 24 months * participation in another non-purely observational study * patients unable to understand treatment and / or study and / or providing adequate informed consent * any condition, that in the opinion of the physician responsible for the patient, contraindicates any of the treatments of the study * microalbuminemia
glycine "deficiency" and the kinetics of acylglycine in morbid obesity

Conditions: Morbid Obesity; Glycine; Metabolic Disorder

Summary: this study aims to evaluate the effects of oral glycine supplementation on plasma glycine concentration, intracellular glutathione (gsh) concentration, plasma acylglycine concentration, urine acylglycine concentration, and insulin resistance in subjects with morbid obesity. this is an open-labelled trial. 20 adults with morbid obesity will be recruited. following screening and baseline metabolic evaluations, eligible subjects will be given oral glycine supplements for 14 ± 5 days. upon completing glycine supplementation, subjects will return for their post-supplement metabolic assessment. the investigators hypothesize that oral glycine supplementation in morbidly obese patients normalizes plasma glycine concentration, increases intracellular gsh concentration, increases plasma and urinary acylglycine concentration, and improves insulin resistance.


Eligibility criteria:
inclusion criteria: 1. age: 21-65 years 2. bmi ≥ 32.5 kg/m2 3. able to provide informed consent 4. able to maintain present diet throughout the study duration exclusion criteria: 1. weight \> 150 kg 2. type 2 diabetes mellitus 3. allergy to soy 4. ongoing treatment with weight-loss medications (e.g. orlistat, phentermine, liraglutide) 5. systemic steroid usage (eg. prednisolone, hydrocortisone, cortisone, dexamethasone) 6. renal impairment (estimated creatinine clearance estimated by cockcroft-gault equation \< 60 ml/min) 7. haemoglobin concentration \< 10 g/l 8. serum alanine aminotransferase or aspartate aminotransferase above 2x upper limit of normal 9. uncontrolled hypertension (bp \> 180/110 mmhg) 10. pregnancy 11. nursing mothers 12. uncontrolled thyroid disease 13. surgery requiring general anaesthesia within 4-weeks before enrolment 14. psychiatric disorders requiring medication 15. significant alcohol intake (\> 1 unit per day for women and \> 2 units per day for men) 16. cancer within the last 3-years (except squamous cell and basal cell cancer of the skin) 17. any factors likely to limit adherence to study protocol

Keywords: morbid obesity insulin resistance glycine metabolism
web based cbt-i in patients with osa and insomnia

Conditions: Obstructive Sleep Apnea; Insomnia

Summary: obstructive sleep apnea (osa) and insomnia often occur in the same patient. recent studies have demonstrated the efficacy of cognitive behavioral therapy (cbt-i) in patients with insomnia and osa. our aim is to verify the efficacy of web based cbt-i in patients with osa and insomnia and the effect of web based cbt-i on the acceptance and adherence to cpap (continuous positive airway pressure) therapy.

obstructive sleep apnea is one of the most common sleep disorders with high prevalence in males sex, is often associated with insomnia. the presence of both sleep disorders generates a vicious circle that exacerbates the clinical picture, makes difficult to accept and adhere to cpap therapy and increase cardiovascular risk. cbt-i is considered the best treatment for insomnia and recent research has demonstrated the efficacy of cbt-i also when insomnia is associated with osa. after six month of treatment we will test the efficacy of web-based cbt-i in patients with osa and insomnia in comparison to one session of psycho education on sleep, osa, insomnia, the interaction among them and the influence on cpap adherence.

Eligibility criteria:
inclusion criteria: * age ≥18 * apnea-hypopnea index (ahi) ≥5 exclusion criteria: * complex sleep apnea * ahi \>35 * psychiatric comorbidies

Keywords: obstructive sleep apnea insomnia web based cbt-i cpap treatment rehabilitation
right-sided retroflexion with standard adult versus pediatric colonoscopes

Conditions: Colonic Neoplasms

Summary: screening colonoscopy has been shown to be less effective in preventing colorectal cancer in the proximal colon compared to the distal colon. possible reasons for this include bowel preparation often being worse in the proximal colon as well as flat depressed lesions being more common in the proximal colon. retroflexion is commonly regarded as standard practice in the rectum, but retroflexion in the proximal colon is not currently routinely performed due to concerns of perforation and possibly because of the increased time required. proximal colon retroflexion has been shown to be safe and effective without any complications, but data regarding ability to retroflex with certain types of colonoscopes is limited. endoscopists interchangeably use standard adult colonoscopes or pediatric colonoscopes. studies have not been performed to comparatively evaluate the success rates of standard adult and pediatric colonoscopes and whether either type of instrument confers a greater polyp detection rate.


Eligibility criteria:
inclusion criteria: * adult patients over the age 18 undergoing screening or surveillance colonoscopy exclusion criteria: * age less than 18 * pregnant * history of ulcerative colitis or crohn's disease * history of polyposis syndromes * history of colon resection * colonoscopy being performed for diagnostic purposes (ie. bleeding, abdominal pain, alternating bowel habits)
does the harmonic scalpel reduce blood loss and or time in major head and neck cancer surgery undergoing major surgery for oral cavity squamous cell carcinoma?

Conditions: Oral Cavity Squamous Cell Carcinoma, Treated With Surgery

Summary: the harmonic scalpel is a tool that may reduce operative blood loss. some studies also indicate it may result in faster surgery. a recently published randomized study from our group shows the harmonic scalpel reduces blood loss in neck dissection but it did not offer any reduction in or time. the present study investigates the utility of the harmonic scalpel in resections involving removal of oral cavity tissues as well as the neck. oral cavity resections are especially prone to blood loss and we believe the harmonic scalpel will confer benefits in this type of surgery, potentially reducing the need for blood transfusion.


Eligibility criteria:
inclusion criteria: * age \> 18 years * oral cavity scc * primary surgery including either uni or bilateral neck dissection (levels i-iv) exclusion criteria: * previous treatment for head and neck cancer * unable or unwilling to give informed consent * history of bleeding disorder * other contraindications to surgery

Keywords: oral cavity squamous cell carcinoma head and neck cancer oral cancer
exogenous melatonin in postmenopausal women with insomnia

Conditions: Insomnia

Summary: the aim of the study is to assess the effect of exogenous melatonin, 2 mg sr, 60 minutes before bedtime for 15 days, on the sleep and circadian rhythms of postmenopausal women with insomnia in a randomized crossover placebo-controlled study.

eligible participants will be contacted by the research team to provide informed consent for the study. once the screening phase is completed, they will be ready to start the study consisting of: a) a \~2-week ambulatory phase at home with melatonin or placebo treatment; b) a 2-week wash-out period; c) same as a with the opposite treatment; part a: the research project will start with a 16-day ambulatory data-collection period during which participants will receive either melatonin or a placebo. they will take 2 mg of exogenous melatonin in a slow release formulation (or placebo), 60 mins prior to bedtime for 15 days. participants will be instructed to go to bed at a regular time and stay in darkness for 8 consecutive hours each night, trying to sleep. part b: throughout this period, all participants will stop taking their melatonin/placebo pills. after at least 2 weeks, they will prepare to participate to the other study condition. parts c: repetition of ambulatory phase 1 (part a) except that participants who received the active treatment will now receive placebo and vice versa.

Eligibility criteria:
inclusion criteria: * insomniac women will meet the diagnostic criteria for persistent insomnia as described in the diagnostic and statistical manual of mental disorders, 5th edition (dsm-5). they will report subjective sleep onset and/or maintenance difficulties associated with impaired daytime functioning at least 3 times a week, for at least 3 months. sleep disturbances will be coincident with the onset of the menopausal transition. * postmenopausal women will have amenorrhea for at least 12 months. * participants will be drug-free at the time of study, and will have a history of only moderate or no use of coffee (≤3 cups/day), tobacco (≤ 10 cigarettes/day), alcohol (≤ 15 drinks/week), or other compounds. exclusion criteria: * evidence of psychopathology on the structured clinical interview for dsm-5, the seasonal pattern assessment questionnaire, the beck depression inventory, and the spielberger state trait anxiety inventory. * a history of prior gynecological pathology or medical condition that can affect the study results, including bilateral oophorectomy or endocrinopathy, and will not have used investigational drugs within 4 weeks of the study. * a history of night work or transmeridian travel (across \>2 time zones) in the 2 months prior to the study. * evidence of sleep apnea (apnea/hypopnea index \> 15 per hour of sleep) or restless legs, or periodic limb movements during sleep (number of plms \>15 per hour of sleep).

Keywords: menopause aging melatonin circadian rhythms sleep alertness
effect of probiotics on sputum inflammation and pulmonary infections in patients with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: patients with cystic fibrosis have multiple pulmonary infections and repeated antibiotic treatment. these factors taken together with high sputum viscosity and slow motility of the gastrointestinal tract-may change the pathogenicity and consistency of the intestinal pathogens. part of the pulmonary infections in cf patients are due to intestinal pathogens. a pilot study performed by the researchers using probiotics in cf patients showed a decrease in the rate of pulmonary infections. therefore,we planned a double-blind placebo-controlled trial to examine the effect of probiotics on pulmonary infections, sputum bacteria and sputum inflammatory markers in cf patients.

patients with cystic fibrosis have multiple pulmonary infections and repeated antibiotic treatment. these factors taken together with high sputum viscosity and slow motility of the gastrointestinal tract-may change the pathogenicity and consistency of the intestinal pathogens. part of the pulmonary infections in cf patients are due to intestinal pathogens. a pilot study performed by the researchers using probiotics in cf patients showed a decrease in the rate of pulmonary infections. therefore,we planned a double-blind placebo-controlled trial to examine the effect of probiotics on pulmonary infections, sputum bacteria and sputum inflammatory markers in cf patients. the study will be a cross-over study of probiotic and placebo arms.

Eligibility criteria:
inclusion criteria: * cystic fibrosis mild to moderate * at least 3 pulmonary exacerbations requiring antibiotics per year * pseudomonas aeruginosa in the sputum * able to produce sputum exclusion criteria: * severe pulmonary disease * less than 3 pulmonary exacerbations per year * unable to produce sputum

Keywords: cystic fibrosis probiotics pulmonary infections
efficacy and safety of fingolimod (fty720) in patients with relapsing-remitting multiple sclerosis

Conditions: Multiple Sclerosis

Summary: this study assessed the safety, tolerability and efficacy of two doses of oral fingolimod compared to placebo on efficacy parameters in patients with relapsing-remitting multiple sclerosis (rrms).

this randomized, multicenter, parallel-group study consisted of 2 phases: a 24-month double-blind, randomized, multicenter, placebo-controlled, parallel-group study and an extension phase which consisted of a dose-blinded period and an open-label period. in the core phase, patients were randomized to receive a fixed dose of fingolimod (0.5 mg/day), fingolimod (1.25 mg/day) or placebo for up to 24 months. for the extension phase, patients who were treated with fingolimod during the core phase continued treatment at the assigned dose level, while those previously treated with placebo during the core phase were re-randomized in a 1:1 ratio to receive one of the two doses of fingolimod (1.25 mg or 0.5 mg). all patients in the extension received blinded investigational drug: fingolimod 1.25 mg and 0.5 mg in capsules for oral administration once daily until the decision to discontinue the fingolimod 1.25 mg dose became effective and subsequently all patients were switched to open-label fingolimod 0.5 mg. with the implementation of amendment 11, the 1.25 mg dose was discontinued and all patients were switched to fingolimod 0.5 mg dose. with the implementation of amendment 12, all patients treated with placebo in the fingolimod core phase were switched to treatment with 0.5 mg fingolimod per day. the extension phase continued until all patients either discontinued or transferred to study cfty720d2399 (nct01201356; initiated in september 2010).

Eligibility criteria:
inclusion criteria: * male and female patients between ages 18-55 with a diagnosis of multiple sclerosis * patients with a relapsing-remitting disease course * patients with expanded disability status scale (edss) score of 0-5.5 exclusion criteria: * patients with other chronic disease of the immune system, malignancies, acute pulmonary disease, cardiac failure, etc. * pregnant or nursing women for inclusion in the extension phase patients should complete the 24 month core study with or without 24 months on study drug. if a patient discontinued study drug during the core study due to an adverse event, serious adverse event, laboratory abnormality etc. they would be excluded from the extension phase. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: fingolimod fty720 relapsing-remitting multiple sclerosis ms rrms
invasive and clinical features in patients with brugada syndrome undergoing catheter ablation

Conditions: Brugada Syndrome

Summary: this clinical trial aims to learn about the electrophysiological and clinical effects of radiofrequency catheter ablation in patients with brugada syndrome. the main questions it seeks to answer are: * what are the immediate effects of catheter radiofrequency ablation in cardiac electrophysiology? * what is the relation between invasive and clinical features in patients with brugada syndrome undergoing ablation? researchers will compare ablation and control groups to see if there is a difference in clinical and invasive markers of the disease in one year of follow-up.

brugada syndrome (bs) is an electric cardiac disorder characterized by a typical electrocardiographic pattern and an increased risk of cardiac arrhythmias and sudden death. most arrhythmic events occur during rest, fever or under circumstances of increased vagal activity. in the last decade, catheter ablation has emerged as a valuable and potentially curative therapy for patients with bs. however, little is known about its mechanisms or long-term effects on clinical and invasive markers. this prospective, single-centre, randomized, sham-controlled, and masked pilot study will investigate the impact of catheter ablation in 20 patients with brugada syndrome, who will be randomized to ablation or control group, with a 1:1 allocation ratio and clinically followed for 12 months.

Eligibility criteria:
inclusion criteria: * patients with a type 1 brugada ecg pattern, as characterized by st-segment elevation (≥2mm) with upward concavity associated with t-wave inversion, in at least one of the right precordial leads, positioned at the second, third or fourth intercostal space, either spontaneously or induced by a provocative test with class i anti-arrhythmic drugs according to vaughan williams * patients clinically stable for at least six months before the enrollment * able to cope with follow-up visits up to one year after the intervention * patients who have signed the written informed consent exclusion criteria: * pregnant women * patients with structural heart disease * patients with a known cardiac or systemic autonomic disorder * patients with a history of previous right ventricular outflow tract ablation

Keywords: brugada syndrome radiofrequency catheter ablation electroanatomic mapping invasive electrophysiological study
ultra low frequency spinal cord stimulation for chronic low back pain

Conditions: Chronic Pain; Chronic Low-back Pain

Summary: the presidio medical ultra low frequency (ulf™) spinal cord stimulation (scs) system is intended to provide pain relief to participants who have been clinically diagnosed with chronic low back pain with or without leg pain.

this is a prospective, open-label, multi-center clinical trial in which participants with chronic low back pain (clbp) with/without leg pain will be invited to enroll and undergo treatment with the ulf scs system. the purpose of this study is to evaluate the safety and effectiveness of ulf scs over a 2-year period.

Eligibility criteria:
inclusion criteria: 1. diagnosed with chronic low back pain with/without leg pain (vas ≥60mm for back pain for the past week), which has been refractory to conservative therapy for a minimum of 3 months. 2. be on no or stable pain medications, as determined by the investigator, for at least 28 days prior to the screening visit. 3. is currently considered medically stable as judged by investigator. 4. able to operate the scs device (e.g., using remote control) and charge the device appropriately. 5. determined to be a good surgical candidate by the investigator. 6. willing to sign the human research ethics committee (hrec) approved informed consent and deemed capable of complying with the requirements of the study protocol. 7. willing to stay on stable medications until implantable pulse generator (ipg) activation (i.e., from ipg implant to ipg activation, except for usual postoperative medications required following ipg insertion). 8. able to comply with study requirements and attend all scheduled visits. 9. eighteen (18) years of age or older. 10. literate, able to speak english and able to complete questionnaires independently. exclusion criteria: 1. diagnosis of active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance, intervention and/or ability to evaluate treatment outcome as assessed by a clinical psychologist or psychiatrist in a psychological assessment performed at baseline. 2. chronic pain in any area other than back or legs, such that it precludes subject's ability to assess their pain for the primary indication of chronic low back pain as determined by investigator. 3. previous experience with implantable neuromodulation devices (e.g., spinal cord stimulation, peripheral nerve stimulation, dorsal root ganglion stimulation). 4. opioid usage with average total daily morphine equivalent dose (med) of \>60 mg. 5. a known need for an mri or surgery within a 2-week period of the screening visit through the end of the study. 6. female candidates of childbearing potential that are pregnant (confirmed by positive urine/blood pregnancy test) or plan to get pregnant during the duration of the study. 7. subject is participating in another interventional clinical trial.

Keywords: neuromodulation spinal cord stimulation
vitamin c supplementation plus hypoglycemic agents versus hypoglycemic agents alone in type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: null hypothesis: no significant effect of vitamin c 500 mg supplementation on the severity of micro-vascular complications of type 2 diabetes mellitus (dm). alternative hypothesis: there is a significant effect of vitamin c 500mg supplementation on the severity of the micro-vascular complications of type 2dm.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of type 2dm * patients in good health * receiving oral hypoglycemic drugs exclusion criteria: * insulin dependent diabetes * receiving vitamin complex * smoking * renal disease * liver disease

Keywords: vitamin c oxidative stress type 2dm